Zobrazeno 1 - 10
of 20
pro vyhledávání: '"Eric Sheinin"'
Autor:
Eric Sheinin, Roger L. Williams, Lynn C. Yeoman, Lokesh Bhattycharyya, Roger Dabbah, Walter W. Hauck
Publikováno v:
The AAPS Journal. 7:E786-E812
This article examines the United States Pharmacopeia (USP) and its role in assessing the equivalence and inequivalence of biological and biotechnological drug substances and products-a role USP has played since its founding in 1820. A public monograp
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::95edafb7d5ff8ecab5e824576f4a74b7
https://doi.org/10.1208/aapsj070477
https://doi.org/10.1208/aapsj070477
Autor:
Margareth Marques, Eric Sheinin, William Brown, Walter W. Hauck, Thomas C. Foster, Roger L. Williams, Todd L. Cecil
Publikováno v:
Pharmaceutical Research. 22:182-187
The performance test is one of a series of tests that compose the specification in a United States Pharmacopeia (USP) dosage form monograph. For an orally administered, nonsolution dosage form, it is usually satisfied by either a dissolution or disin
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::41678d0898955c07462d7cb784ce7896
https://doi.org/10.1007/s11095-004-1184-4
https://doi.org/10.1007/s11095-004-1184-4
Autor:
Eric Sheinin, Roger L. Williams
Publikováno v:
Pharmaceutical Research. 19:217-226
Advice to the pharmaceutical industry regarding the chemistry, manufacturing, and controls and microbiology (sterility assurance) information to be included in regulatory submissions to the Center for Drug Evaluation and Research (CDER) can be found
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::a5ab17442dcff42b912a7d81058b4029
https://doi.org/10.1023/a:1014437513188
https://doi.org/10.1023/a:1014437513188
Autor:
Nicholas M. Mohr, Claudia C Okeke, Roger L. Williams, Thomas Medwick, Desmond G Hunt, Eric Sheinin
Publikováno v:
Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition ISBN: 9781841848204
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8aecd80fad1e018faa90d701b66576dc
https://doi.org/10.1081/e-ept4-120042835
https://doi.org/10.1081/e-ept4-120042835
Autor:
Todd Cecil, Eric Sheinin
An overview of impurity evaluations of drug substances and products by HPLC is given in this chapter, from regulatory and laboratory viewpoints.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::9e11bedfc300f50f4dbf61ed3362b71c
https://doi.org/10.1016/s0149-6395(05)80058-3
https://doi.org/10.1016/s0149-6395(05)80058-3
Autor:
Eric Sheinin, Roger L. Williams, Todd L. Cecil, Stefan Schuber, R. Dabbah, L. Bhattacharyya, D. Roll
Publikováno v:
Pharmaceutical research. 21(10)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::62a0aa2e336762107a5c8c36717411ad
https://pubmed.ncbi.nlm.nih.gov/15553215
https://pubmed.ncbi.nlm.nih.gov/15553215
Autor:
Eric, Sheinin, Roger, Williams
Publikováno v:
Pharmaceutical research. 19(3)
Advice to the pharmaceutical industry regarding the chemistry, manufacturing, and controls and microbiology (sterility assurance) information to be included in regulatory submissions to the Center for Drug Evaluation and Research (CDER) can be found
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::9a79a8f7c3eed5a3eaef9056d1852d9e
https://pubmed.ncbi.nlm.nih.gov/11934225
https://pubmed.ncbi.nlm.nih.gov/11934225
Publikováno v:
Validation of Active Pharmaceutical Ingredients, Second Edition
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::490bf717bd4f6389e879a218783b3853
https://doi.org/10.1201/b14415-13
https://doi.org/10.1201/b14415-13
Autor:
Walter W. Hauck, Thomas Foster, Eric Sheinin, Todd Cecil, William Brown, Margareth Marques, Roger L. Williams
Publikováno v:
Pharmaceutical Research; Feb2005, Vol. 22 Issue 2, p182-187, 6p
Publikováno v:
Pharmazeutische Industrie (Pharmind). 2007, Vol. 69 Issue 5, p624-628. 5p.